Efficacy and Tolerability of Lercanidipine in Patients with Mild to Moderate Essential Hypertension

Abstract

The objective of this study was to compare the efficacy and tolerability of lercanidipine and slow-release (SR) nifedipine in patients with mild to moderate essential hypertension. After a 3-week placebo run-in, 130 patients aged 18-70 years entered a 16-week double-blind (doubledummy) multicenter study. Patients were randomized to parallel groups receiving either 10 mg lercanidipine once daily or 20 mg nifedipine SR twice daily for 4 weeks. Dose doubling and the addition of 12.5 mg hydrochlorothiazide q.d. (titrated to 25 mg q.d. in non-responders) were allowed in non-responding patients or when diastolic blood pressure (DBP) persisted higher than 90 mm Hg. After 4 weeks of treatment, DBP equally decreased in both the lercanidipine (−9.5 mm Hg) and the nifedipine SR (−10.3 mm Hg) groups. Similar changes were also observed in systolic blood pressure (SBP) after lercanidipine (−11.8 mm Hg) and nifedipine SR (−12.4 mm Hg) treatment. At this time, normalized patients were 50.9% and 52.5% in each group, respectively. Dose doubling and then addition of hydrochlorothiazide was found to be effective in further reducing both DBP and SBP in previously non-responding patients, leading to a high percentage of normalized patients either with lercanidipine (87.5%) or with nifedipine SR (98.1%) treatment. Heart rate did not change, and tolerability was good in both groups. Lercanidipine was found to be as effective as nifedipine SR for lowering blood pressure in hypertensive patients (either alone or in combination with the diuretic hydrochlorothiazide). The low incidence of side effects, including tachycardia, indicates a good tolerability profile for this new drug.